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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinary homocystine (nonquantitative) test system
Product CodeLPS
Regulation Number 862.1377
Device Class 2

MDR Year MDR Reports MDR Events
2017 8 8
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 8 8
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Axis-Shield Diagnostics, Ltd. II Dec-26-2019
2 Roche Diagnostics Operations, Inc. II Dec-13-2019
3 Siemens Healthcare Diagnostics, Inc. II Feb-21-2017
4 Tosoh Bioscience Inc II Dec-22-2018
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